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New brain bleed surgery could save lives and reduce disability

NCT ID NCT04434807

Disease control Sponsor: University of Melbourne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new, less invasive surgery to remove blood clots from the brain after a severe stroke caused by bleeding. The surgery is done within 8 hours of symptoms starting. About 240 adults with large brain bleeds will be randomly assigned to either this surgery or standard medical care. The goal is to see if the surgery leads to better recovery and less disability after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
minimally invasive surgery using the Aurora surgiscope and evacuator
What this could lead to
If successful, this could offer a safer, more effective way to treat severe brain bleeds, potentially improving recovery and reducing disability.
What could go wrong
This is a mid-stage trial with 240-434 participants. Surgery carries risks like infection or rebleeding, and the benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume 2. Age ≥18 years 3. Surgery can commence within 8 hours of symptom onset (the time the patient was last known to be well) or, in patients with wake-up onset, within 8 hours of the time the patient awoke with symptoms. Patients presenting with small ICH (volume \<20mL) with clinical deterioration judged due to ICH hematoma expansion meeting volume criteria may be randomized if surgery can commence within 8 hours of clinical deterioration 4. Moderate neurological deficit (NIHSS≥6) 5. Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week). 6. CTA or MRA is performed and does not show an underlying vascular lesion Exclusion Criteria: 1. Brainstem ICH 2. ICH secondary to trauma, where brain injury is judged more likely to be due to the broad effects of trauma rather than the focal ICH. 3. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR\>1.4). 4. Platelet count \<75,000 5. Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion. 6. Recent (\<12 hours) parenteral GPIIb/IIIa antagonist. 7. Recent (\<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment. 8. Participation in any investigational study in the last 30 days 9. Pregnant women (clinically evident) 10. Co-morbidities or advance care directive preventing general anaesthesia for the procedure. 11. Known terminal illness such that the patients would not be expected to survive a year. 12. Planned withdrawal of care or comfort care measures. 13. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intra cerebral hemorrhage Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • John Hunter Hospital

    RECRUITING

    Newcastle, New South Wales, 2305, Australia

  • Liverpool Hospital

    RECRUITING

    Sydney, New South Wales, 2170, Australia

  • Monash Medical Centre

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Prince of Wales Hospital

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    NOT_YET_RECRUITING

    Brisbane, Queensland, 4102, Australia

  • Royal Prince Alfred Hospital

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2050, Australia

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Austin Hospital

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3084, Australia

  • The Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • The Royal Brisbane and Women's Hospital

    RECRUITING

    Brisbane, Queensland, 4029, Australia

  • The Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Westmead Hospital

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2145, Australia

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